Carpmaels and A&O Shearman file first SPC suit at UPC for Merz against Viatris

The German pharmaceutical company Merz has filed a PI action against Viatris at the Paris local division. According to JUVE Patent information, this marks the first SPC case at the UPC. Does the pharmaceutical industry now have confidence in the new court?

The UPC moves quickly. On 31 July, Merz Therapeutics, the US subsidiary of German pharmaceutical company Merz, revoked the opt-out from the UPC system for its EP 2 377 536. On the same day, Laëtitia Bénard, partner at A&O Shearman in Paris, filed a request for a preliminary injunction against Viatris at the Paris local division (case ID: ACT_33980/2025).

EP 536 is an SPC that covers the multiple sclerosis drug fampridine, which Merz markets under the brand name Fampyra. The drug aims to improve walking ability in multiple sclerosis patients.

The expiry of the SPC next year likely prompted Viatris to launch a generic version of Fampyra in France under the brand name Fampidrin Viatris LP. Merz now seeks to prevent this through the UPC lawsuit.

According to JUVE Patent sources, there are no parallel national lawsuits between the companies in France.

The Paris local division will hear the preliminary injunction case in English. Alongside presiding judge Camille Lignières, French judge Carine Gillet and Belgian judge Samuel Granata complete the panel.

German market already open to generics
Most European countries currently have no generic Fampyra products on the market, except Germany. This is because US company Acorda originally owned the patent, while Biogen held an exclusive licence and sold Fampyra.

In 2022, Biogen and Acorda attempted to keep generic products off the German market with a preliminary injunction. However, the Munich Regional Court dismissed Biogen’s application. Previously, the Federal Patent Court had dismissed revocation cases against two important Fampyra patents on formal grounds, but had indicated that one patent was likely invalid in a preliminary assessment.

The Federal Court of Justice later ordered the Federal Patent Court to rehear the German revocation actions, including against EP 536. As a result, companies such as ratiopharm and Accord currently have generic products on the German market.

Merz acquired several products from Acorda in 2024, including Fampyra. The upcoming expiration of the SPC likely motivated Merz to file UPC claims against Viatris regarding market entry in France. While Viatris could file a revocation counterclaim against EP 536, the risk and consequences of patent revocation next year at the earliest should be manageable for Merz.

According to JUVE Patent sources, this is not only the first SPC action at the UPC but also the first PI action in Paris. So far the pharmaceutical industry has shown reluctance to file UPC lawsuits, with SPC cases considered particularly unlikely.

However, pharmaceutical manufacturers are gradually warming to the UPC. In July, GlaxoSmithKline filed several lawsuits concerning mRNA patents against Moderna, Pfizer and BioNTech.